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What is a Clinical Trial?
A clinical trial is the way by which medical researchers
or doctors can study the benefits and risks of using a new
treatment for a particular disease in human subjects.
The reasons for conducting clinical trials are:
| Toxicity
|
To
find out if a treatment is safe to use in humans |
|
Efficacy |
To
find out if it does the job that it is designed for |
| Comparative
Efficacy |
To
see if the drug(s) is/are better than any others that
are being used for this particular disease |
| Drug
Interactions |
To
determine if the drug can be used at the same time as
other drugs |
Why participate in a clinical trial?
There are several good reasons to take part in a clinical
trial, including:
- The chance to receive a new (although experimental) treatment
before it is widely available
- The opportunity to receive regular medical monitoring,
along with other services, at little or no financial cost
to the participant
- The satisfaction of making a contribution to scientific
knowledge about the disease, that may make a difference
to other people who are in the same position.
When should I consider entering a trial?
If you are sick and have not been helped by an approved treatment
a doctor may discuss with you the possibility of entering
a clinical trial. This may well be the best option to treat
the current disease.
Most people, however, make the decision to enter a trial
when they are relatively well, and have had time to consider
the risks and benefits of the experimental drug that is being
offered.
What are the potential risks?
The biggest risks in a clinical trial come from what is NOT
known about the treatments. There are no guarantees that the
experimental drug being offered will be any better than another
treatment- or better than no treatment at all.
What is Informed Consent?
The law protects us from being experimented on against our
will, by requiring us to give "informed consent".
The principle of informed consent requires that people who
are being asked to join a clinical trial understand a number
of important things about the study.
These include:
- The purpose of the study
- The drugs that will be
used
- The possible dangers
or side effects of the drugs being used
- The possible benefits
of the drugs under study
- The number of clinical
visits required
- What tests will be conducted
at these visits
- What will happen to the
participant at the conclusion of the study.
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Other important questions to think about are:
| 1 |
What are my rights? |
| 2 |
What are my responsibilities
when in a trial? |
| 3 |
What is it like being
in a trial? |
| 4 |
What happens at the end
of a trial? |
| 5 |
How do trials work? |
| 6 |
Am I eligible for the
trial? |
| 7 |
Where do clinical trials
take place? |
| 8 |
How do I find out about
clinical trials |
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